15 Participants Needed

Brain & Muscle Stimulation for Stroke Rehabilitation

DA
Overseen ByDavid A Cunningham, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that lower the seizure threshold, as decided by the study physician.

What data supports the effectiveness of this treatment for stroke rehabilitation?

Research shows that transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, is associated with significant motor function improvement in stroke patients, especially when used in repeated sessions.12345

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans when used at an intensity of 4 mA or less for up to 60 minutes per day, with no severe complications reported in over 33,200 sessions. However, it can cause mild skin irritation, and caution is advised for potentially vulnerable groups like children and the elderly.678910

How is the treatment 'Brain & Muscle Stimulation for Stroke Rehabilitation' different from other stroke rehabilitation treatments?

This treatment uses transcranial direct current stimulation (tDCS), a non-invasive method that applies a small electrical current to the brain to enhance motor recovery and improve daily living activities after a stroke, which is different from traditional physical therapies that do not involve direct brain stimulation.511121314

Research Team

DA

David A Cunningham, PhD

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

This trial is for stroke survivors over 21 years old with chronic upper limb hemiplegia, who can follow commands and have some finger movement. They must be medically stable, able to sit unassisted, and at least 6 months post-stroke. Excluded are pregnant individuals, those with other neurological conditions or severe pain in the affected limb, recent botox injections in the arm muscles, certain metal implants or electronic devices.

Inclusion Criteria

I can fully move and use my unaffected arm and hand.
I can follow complex instructions and remember things well.
Medically stable
See 9 more

Exclusion Criteria

I cannot move my hand or shoulder without severe pain.
I have seizures that are not controlled by medication.
I have a neurological condition besides a past stroke affecting my arm.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive brain stimulation and neuromuscular electrical stimulation to improve hand motor control

6 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • electrical stimulator
  • transcranial direct current stimulation
Trial OverviewThe study tests how non-invasive brain stimulation (tDCS) combined with functional electrical stimulation affects hand motor control in stroke patients. It explores optimal timing and delivery methods of these treatments to improve hand function.
Participant Groups
5Treatment groups
Experimental Treatment
Placebo Group
Group I: unconventional tDCS preceding CCFESExperimental Treatment1 Intervention
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
Group II: unconventional tDCS concurrent with CCFESExperimental Treatment1 Intervention
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
Group III: conventional tDCS preceding CCFESExperimental Treatment1 Intervention
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
Group IV: conventional tDCS concurrent with CCFESExperimental Treatment1 Intervention
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
Group V: sham tDCS with CCFESPlacebo Group1 Intervention
sham tDCS preceding and concurrent with CCFES

electrical stimulator is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Transcranial Direct Current Stimulation (tDCS) for:
  • Stroke rehabilitation
  • Motor disorders
🇪🇺
Approved in European Union as Transcranial Direct Current Stimulation (tDCS) for:
  • Stroke rehabilitation
  • Motor disorders

Find a Clinic Near You

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials
125
Recruited
22,600+

Findings from Research

In a study involving 10 chronic stroke patients, bihemispheric transcranial direct current stimulation (tDCS) combined with therapy led to significant improvements in motor function, with an average increase of 8.2 points on the Upper-Extremity Fugl-Meyer scale after two 5-day treatment periods.
The first treatment period showed a larger improvement (5.9 points) compared to the second period (2.3 points), indicating that while tDCS is effective, the benefits from multiple sessions may not increase linearly, which is important for future rehabilitation studies.
Combined central and peripheral stimulation to facilitate motor recovery after stroke: the effect of number of sessions on outcome.Lindenberg, R., Zhu, LL., Schlaug, G.[2021]
Transcranial direct current stimulation (tDCS) significantly improves motor function in stroke patients, with notable effects from both cathodal stimulation of the unaffected hemisphere and anodal stimulation of the affected hemisphere, as shown in a study involving multiple sessions and a blinded evaluation.
Consecutive daily sessions of tDCS resulted in lasting improvements in motor function for up to two weeks after treatment, suggesting that this simple and safe technique could be an effective rehabilitation tool for stroke patients.
Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients.Boggio, PS., Nunes, A., Rigonatti, SP., et al.[2022]
Transcranial direct current stimulation (TDCS) is a noninvasive brain stimulation technique that can help in understanding brain function and may aid in the recovery of patients after a stroke.
TDCS has the potential to enhance neuroplasticity, which is crucial for stroke recovery, by modulating brain activity and facilitating rehabilitation efforts.
Transcranial direct current stimulation in stroke recovery.Schlaug, G., Renga, V., Nair, D.[2022]

References

Combined central and peripheral stimulation to facilitate motor recovery after stroke: the effect of number of sessions on outcome. [2021]
Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients. [2022]
Transcranial direct current stimulation in stroke recovery. [2022]
Different Therapeutic Effects of Transcranial Direct Current Stimulation on Upper and Lower Limb Recovery of Stroke Patients with Motor Dysfunction: A Meta-Analysis. [2020]
tDCS does not enhance the effects of robot-assisted gait training in patients with subacute stroke. [2018]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]
Safety of transcranial direct current stimulation in healthy participants. [2021]
A safety study of 500 μA cathodal transcranial direct current stimulation in rat. [2020]
Effect of tDCS stimulation of motor cortex and cerebellum on EEG classification of motor imagery and sensorimotor band power. [2018]
Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. [2023]
[Non-invasive direct current stimulation of the brain: a new technique for stroke rehabilitation]. [2018]
Beta-frequency EEG activity increased during transcranial direct current stimulation. [2014]